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Levetiracetam Treatment of Children With Subclinical Sleep-Activated Epileptiform Activity (SSEA)

University of Oslo (UIO) logo

University of Oslo (UIO)

Status and phase

Unknown
Phase 4

Conditions

CSWS
Subclinical Sleep-Activated Epileptiform Activity

Treatments

Drug: levetiracetam

Study type

Interventional

Funder types

Other

Identifiers

NCT00393614
S06080
SLV 200604331
EudraCT number 2006-000795-32

Details and patient eligibility

About

In clinical practice at the National centre for epilepsy (SSE) in Norway we see many children who have subclinical epileptiform activity in EEG that increases substantially during slow wave sleep (SSEA; subclinical sleep-activated epileptiform activity). They may or may not have seizures. Hence, according to the definition some children with SSEA do not suffer from epilepsy because they do not experience seizures. Many of these children have symptoms such as: attention deficit hyperactivity disorders (AD/HD), dyslectic problems, sleep problems, tantrums or autistic symptoms . We hypothesize that this subclinical epileptiform activity during slow sleep may act negatively on cognitive functions, language and behaviour in some children; even when the spike-wave discharges are less frequent than in CSWS (continuous spike-waves during slow sleep).

Enrollment

30 estimated patients

Sex

All

Ages

5 to 10 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Children 5-10 years
  • IQ > 50

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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